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San Diego, California, United States
Onsite
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, Facebook and YouTube. (*in collaboration with AbbVie)
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Provide scientific and technical leadership across drug product development programs from early discovery through commercial launch, ensuring alignment with program goals, timelines, and regulatory expectations
Lead weekly or bi-weekly internal and NBI–CMO/CDMO project team meetings; clearly communicate program progress, risks, resource gaps, and timelines up and down the organization
Design, develop, and scale robust, phase-appropriate formulations and manufacturing processes using Quality by Design (QbD) principles, statistical analysis, and sound scientific methodologies, with a clear path to commercialization
Lead and contribute to process development activities including experimental design (DoE), process modeling, scale-up, validation, and technology transfer to internal and external manufacturing sites
Serve as a subject matter expert (SME) to investigate and resolve complex technical issues across preformulation, formulation, analytical, and manufacturing activities; drive root cause analysis and implement effective solutions
Oversee and collaborate with external partners, including CDMOs and vendors, to ensure appropriate technical capabilities, quality, compliance, and supply of clinical and commercial materials
Act as technical lead and company representative during manufacturing campaigns and on-site activities (“person-in-plant”), providing oversight and ensuring successful execution
Collaborate cross-functionally with internal teams (e.g., Discovery, Chemical Development, Analytical, Clinical, Regulatory, Quality, and Supply Chain) to advance programs and ensure effective knowledge transfer across development stages
Lead or support CMC strategy and execution, including authorship and review of regulatory submissions (e.g., IND, IMPD, NDA, MAA) and development documentation, ensuring scientific rigor and compliance with global regulatory requirements (ICH, FDA, EMA, cGMP)
Drive continuous process verification (CPV) and continuous improvement (CPI) activities through data analysis and monitoring of critical process parameters (CPPs) and critical quality attributes (CQAs)
Provide technical guidance, mentorship, and leadership to team members
Perform other duties as assigned
BS/BA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 6+ years of pharmaceutical industry experience, specifically in a chemistry, analytical, or characterization laboratory setting
MS/MA degree in Chemistry, Biochemistry, Chemical Engineering, or related field and 4+ years of similar experience noted above OR
PhD in Chemistry, Biochemistry, Chemical Engineering, or related field and 2+ years of similar experience noted above; may include postdoc experience
Experience with parenteral drug product development, including monoclonal antibodies, peptides, and conjugates. Experience with combination product design is preferred
Advanced and comprehensive understanding of cGMP requirements across early- and late-stage drug product manufacturing, with a strong quality and compliance mindset
Deep technical expertise in parenteral drug product development, including process design, optimization, scale-up, validation, and lifecycle management
Strong cross-functional understanding of parenteral drug product development from discovery through commercialization, including CMC strategy and regulatory lifecycle considerations
Expertise managing CROs and CMOs/CDMOs supporting preclinical, clinical, and commercial programs
Advanced knowledge of analytical methods, method validation, technology transfer, and stability programs
Extensive knowledge of characterization instrumentation and techniques; evaluates and implements emerging technologies to enhance development capabilities
Demonstrated regulatory expertise authoring and reviewing drug product sections of INDs, NDAs, and other global submissions
Experience contributing to strategic planning, budget management, and portfolio-level decision-making
Experience managing preclinical/clinical Contract Research Organizations and Contract Manufacturing Organizations. Experience preparing INDs & NDAs
Assimilates external scientific literature, competitive intelligence, and emerging technologies for application to internal development programs
Maintains broad knowledge of scientific principles and theories, with intellectual mastery and recognized expertise in one or more scientific disciplines
Understands related functional areas and interdependencies across parenteral drug product development, manufacturing, and regulatory domains
Demonstrates advanced knowledge and judgment in selecting, recommending, and implementing laboratory and manufacturing equipment and technologies
Proven ability to lead multiple teams and influence cross-functional and matrixed organizations; provides technical leadership to junior scientists and indirect teams
Exhibits strong leadership capability, strategic thinking, and organizational awareness
Excellent computer proficiency and data analysis capability
Exceptional communication, analytical thinking, and complex problem-solving skills
Sees the broader organizational impact of decisions across programs, departments, and portfolios
Effectively manages multiple high-priority programs simultaneously with accuracy, efficiency, and accountability
Excellent project management skills, including long-range planning and execution
Holds self and team accountable for results; sets clear objectives and articulates measurable outcomes
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Neurocrine Biosciences is an EEO/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.
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The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.